PBPK Modeling & Simulation

The Next Horizons in Predicting Drug-drug Interactions

Matthew Harwood

Physiologically-based pharmacokinetic (PBPK) modeling has arrived in prime time. This quantitative mechanistic framework, combining physiology with drug information and clinical trial design, has become an integral part of drug discovery and development. PBPK has also gained currency within industry and regulatory agencies. Its applications are numerous, including simulation of pre-clinical, healthy volunteer and special population […]

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Topics: PBPK Modeling & Simulation

What is Model-based Drug Development Worth?

Mark Hovde

If you have ever argued, as we have, for the resources and time needed for model-based drug development (MBDD), you have likely encountered that irritating accountant in the room who says, “Sure, this modeling stuff sounds interesting, but how much MONEY will this save us?” My answer: $97M of savings per New Drug Application (NDA). […]

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Topics: Clinical Pharmacology Strategy

How Modeling and Simulation Technology Impacted the “Class of ’15”

Ellen Leinfuss

It’s been almost 20 years since the FDA approved a group of New Drug Applications (NDA) and Biologic License Applications (BLA) as large as the class of ’15. The 45 approved drugs represent a 10% increase over the prior year and an increase of 114% from the beginning of the decade. What accounts for this […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Is the Maturation of Quantitative Systems Pharmacology a Moonshot?

Mark Hovde

At Certara, we are not afraid to think big. In fact, solving the hardest problems in pharmaceutical R&D is our passion. You might say that some of our ambitions could be described as “moonshots.” After all, they meet the criteria put forth by the Google X moonshot program. We seek to address the huge problem […]

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Topics: Systems Pharmacology